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Last Updated: September 27, 2020

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Details for New Drug Application (NDA): 201187

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NDA 201187 describes OXYMORPHONE HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Hikma, Impax Labs, Par Pharm, Specgx Llc, Sun Pharm Inds Ltd, Ascent Pharms Inc, Aurolife Pharma Llc, Avanthi Inc, Epic Pharma Llc, and Teva, and is included in thirteen NDAs. It is available from eight suppliers. Additional details are available on the OXYMORPHONE HYDROCHLORIDE profile page.

The generic ingredient in OXYMORPHONE HYDROCHLORIDE is oxymorphone hydrochloride. There are nine drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the oxymorphone hydrochloride profile page.
Summary for 201187
Tradename:OXYMORPHONE HYDROCHLORIDE
Applicant:Epic Pharma Llc
Ingredient:oxymorphone hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 201187
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 201187
Suppliers and Packaging for NDA: 201187
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXYMORPHONE HYDROCHLORIDE oxymorphone hydrochloride TABLET;ORAL 201187 ANDA Epic Pharma, LLC 42806-330 42806-330-01 100 TABLET in 1 BOTTLE (42806-330-01)
OXYMORPHONE HYDROCHLORIDE oxymorphone hydrochloride TABLET;ORAL 201187 ANDA Epic Pharma, LLC 42806-331 42806-331-01 100 TABLET in 1 BOTTLE (42806-331-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Dec 15, 2014TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Dec 15, 2014TE:ABRLD:No

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